YY/T 0814-2010 (English Version) PDF

Scope: The test method describes the determination of the number of transvinylidene groups in ultra-high molecular weight polyethylene (UHMWPE) for medical implants. The material should be analyzed using infrared spectroscopy. This test method is formulated in accordance with YY/T 0772.4. The applicability of infrared spectroscopy has been described in other literature reports. This method uses the CH absorption peak (area) centered at 1370 cm to normalize the thickness of the sample, and is validated by an Interlaboratory Study (ILS) in accordance with ASTM E 691. This standard does not attempt to address all safety issues covered, even those relevant to its use. It is the responsibility of the users of this standard to establish appropriate safety and health practices and to clarify the applicability of regulatory limitations prior to application.

YY/T 0814-2010 Referenced Document

ASTM E1421 Standard Practice for Describing and Measuring Performance of Fourier Transform Mid-Infrared (FT-MIR) Spectrometers: Level Zero and Level One Tests*， 2021-09-01 Update
ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
YY/T 0772.4 Surgical Implants Ultra High Molecular Weight Polyethylene Part 4: Oxidation Index Test Method*， 2022-08-17 Update

2010 YY/T 0814-2010 tandard test method for evaluating trans-vinylene yield in irradiated ultra-high-molecular-weight polyethylene fabricated forms intended for surgical implants by infrared spectroscopy